GW Commences Phase I Study of THCV, a Potential Treatment for Obesity and Related Metabolic Disorders
The clinical development programme of its novel cannabinoid product, delta-9-tetrahydrocannabivarin (THCV). THCV has shown promise in pre-clinical studies as a potential treatment for obesity, diabetes and related metabolic disorders.
The Phase I study, in which dosing has commenced, is a randomised, double blind, placebo controlled, dose escalation, safety and tolerability study of single doses of THCV in twelve healthy volunteer subjects. The formulation is an extract from a unique cannabis plant variety bred by GW scientists which exhibits THCV as the principal cannabinoid component. The product is being administered as an oral solution.
GW's pharmacology research team, led by Professor Roger Pertwee at the University of Aberdeen, has shown THCV to be an antagonist at CB1 and CB2 receptors1. In pre-clinical studies, THCV has shown effects on body weight, body fat content, energy expenditure, food intake, and other obesity-related parameters. The human endocannabinoid system is known to play an important role in the regulation of body weight and metabolic homeostasis. To date, the most studied CB1 receptor antagonist is Rimonabant, a new product developed by Sanofi-Aventis.
The primary objective of the Phase I study is to evaluate the safety and tolerability of single doses of formulated THCV compared with placebo. This Phase I clinical study is being carried out at a single centre in the UK and has been designed in accordance with EU guidance notes for the clinical development of new medicinal products in obesity.
Dr Stephen Wright, R&D Director, said, "Today marks the first human dosing of a novel cannabinoid candidate in a key target therapeutic area and is an important milestone for GW as we expand our cannabinoid product pipeline. The pre-clinical evidence for THCV is compelling as a potential treatment for obesity and related metabolic disorders, and we are excited to be advancing this product into clinical trials. Indeed, this is the first of a range of cannabinoids which form part of a programme of work addressing the metabolic syndrome. If this Phase I trial is successful, we shall seek to progress the programme by embarking on studies in obese subjects."
1Thomas A, Stevenson LA, Wease KN, Price Mr, Baillie G, Ross RA, Pertwee RG. Evidence that the Plant Cannabinoid Delta-9-Tetrahydrocannabivarin is a Cannabinoid CB1 and CB2 Receptor Antagonist, Br J Pharmacol. 2005 Dec; 146 (7):917-26.